Notice of Request for Revision to and Extension of Approval of an Information Collection; National Poultry Improvement Plan, 37989-37990 [2021-15185]
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Federal Register / Vol. 86, No. 135 / Monday, July 19, 2021 / Notices
modification described in § 340.1(b)(1),
but enable a developer to more
efficiently obtain a complete loss of
function of a targeted gene. We are also
making available for public review
scientific literature that we consulted
prior to initiating the proposal. The
literature supports exempting plants
with these additional modifications.
Under the first additional genetic
modification proposed, plants would
not be subject to the regulations when
cellular repair of a targeted DNA break
in the same location on two homologous
chromosomes, in the absence of a repair
template, results in homozygous or
heterozygous biallelic mutations, each
of which is a loss of function mutation.
A double strand break followed by
cellular repair often occurs in both
paternal and maternal alleles (biallelic)
during genome editing. As a range of
DNA indels frequently occur after a
double strand break, the mutation in the
paternal allele often differs from the
mutation in the maternal allele. Biallelic
knockout mutations are easily obtained
in conventional breeding through selffertilizing or backcrossing and selection.
In this case, the biallelic mutation is
usually homozygous. However, in cases
where the deletions are not identical but
both deletions lead to a loss of function
of the allele, the phenotype will be the
same as the homozygous biallelic
mutation obtained through conventional
breeding. If both alleles are modified by
indels such that neither allele is
functional, the size, position, and
sequence of the indels within the gene
need not be identical to qualify for the
exemption.
The second additional genetic
modification proposed is a contiguous
deletion of any size resulting from
cellular repair of a targeted DNA break
in the presence of an externally
supplied repair template. The deletion
can occur on one or two homologous
chromosomes. This modification is
similar to the one described in
§ 340.1(b)(1), except that it allows an
externally supplied repair template to
be used. When genome editing is used
to create a single DNA break, a range of
indels result from the cellular repair
mechanism. To limit the range of
mutations recovered and, therefore, to
more efficiently obtain a complete loss
of function of the targeted gene(s), some
developers also add a template to guide
the repair process. To limit this
proposed additional modification to
what is achievable through conventional
breeding, it would only apply to
deletions created by the double strand
break and externally supplied repair
template.
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18:23 Jul 16, 2021
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The third additional genetic
modification proposed is for a change
resulting from cellular repair of two
targeted DNA breaks on a single
chromosome or at the same location on
two homologous chromosomes, when
the repair results in a contiguous
deletion of any size in the presence or
absence of a repair template, or in a
contiguous deletion of any size
combined with an insertion of DNA in
the absence of a repair template. The
insertion cannot result from the
insertion of exogenous construct DNA.
The modifications on two homologous
chromosomes can be heterozygous as
long as each results in a loss of function
of the targeted gene(s). To qualify for the
exemption, the plant must have
mutations that are restricted to a pair of
homologous chromosomes in diploids
and allopolyploids or any two
homologous chromosomes in
autopolyploids. Radiation mutagenesis,
which is commonly used in
conventional breeding, can create any
size deletion. As mutations are typically
detrimental to the organism, what is
achievable in practice is limited by the
viability and fertility of the organism.
Large mutations can be maintained in a
heterozygous state but do not tend to
undergo homozygous inheritance
(Naito, 2005).2 For example, in
Arabidopsis, which has a genome size of
135 Mb (Arabidopsis Genome Initiative,
2000), a radiation-induced deletion of
3.1 Mb was obtained that disrupted 852
genes and was maintainable only as a
heterozygote, presumably because genes
essential for survival are present in the
deleted region (Kazama, et al., 2017).3
Polyploid plants and those with large
genomes are better able to accommodate
even larger deletions (Men et al., 2002).4
For example, in hexaploid wheat, X-ray
mutagenesis was used to create a
mutant, ph1, widely used in breeding
programs, that has a 70 Mb deletion
(Sears, 1977).5 To put the size of this
2 Naito, K., M. Kusaba, N. Shikazono, T. Takano,
A. Tanaka, T. Tanisaka, and M. Nishimura (2005).
Transmissible and nontransmissible mutations
induced by irradiating Arabidopsis thaliana pollen
with gamma-rays and carbon ions. Genetics, 169,
881–889.
3 Kazama, Y., K. Ishii, T. Hirano, T. Wakana, M.
Yamada, S. Ohbu, and T. Abe (2017). Different
mutational function of low- and high-linear energy
transfer heavy-ion irradiation demonstrated by
whole-genome resequencing of Arabidopsis
mutants. Plant J. 92, 1020–1030.
4 Men, A.E., T.S. Laniya, I.R. Searle, I. IturbeOrmaetxe, I. Gresshoff, Q. Jiang, B.J. Carroll, and
P.M. Gresshoff (2002). Fast Neutron Mutagenesis of
Soybean (Glycine soja L.) Produces a
Supernodulating Mutant Containing a Large
Deletion in Linkage Group H. Genome Letters 3:
147–155.
5 Sears, E.A. (1977). An induced mutant with
homoeologous pairing in common wheat. Canadian
J of Genetics and Cytology 19: 585–593.
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37989
wheat deletion in perspective, it is
larger than half of the entire genome of
Arabidopsis. Based on the use of plants
with large deletion mutations in
conventional breeding programs, any
size contiguous deletion created by two
double strand breaks should be
exempted because it falls well within
what could be achieved through
conventional breeding.
After reviewing any comments we
receive, we will announce our decision
regarding the three new modifications
that plants could contain and qualify for
exemption in a subsequent notice.
Authority: 7 U.S.C. 7701–7772 and
7781–7786; 31 U.S.C. 9701; 7 CFR 2.22,
2.80, and 371.3.
Done in Washington, DC, this 14th day of
July, 2021.
Michael Watson,
Acting Administrator, Animal and Plant
Health Inspection Service.
[FR Doc. 2021–15236 Filed 7–16–21; 8:45 am]
BILLING CODE 3410–34–P
DEPARTMENT OF AGRICULTURE
Animal and Plant Health Inspection
Service
[Docket No. APHIS–2021–0032]
Notice of Request for Revision to and
Extension of Approval of an
Information Collection; National
Poultry Improvement Plan
Animal and Plant Health
Inspection Service, Agriculture (USDA).
ACTION: Revision to and extension of
approval of an information collection;
comment request.
AGENCY:
In accordance with the
Paperwork Reduction Act of 1995, this
notice announces the Animal and Plant
Health Inspection Service’s intention to
request a revision to and extension of
approval of an information collection
associated with the National Poultry
Improvement Plan.
DATES: We will consider all comments
that we receive on or before September
17, 2021.
ADDRESSES: You may submit comments
by either of the following methods:
• Federal eRulemaking Portal: Go to
www.regulations.gov. Enter APHIS–
2021–0032 in the Search field. Select
the Documents tab, then select the
Comment button in the list of
documents.
• Postal Mail/Commercial Delivery:
Send your comment to Docket No.
APHIS–2021–0032, Regulatory Analysis
and Development, PPD, APHIS, Station
3A–03.8, 4700 River Road, Unit 118,
Riverdale, MD 20737–1238.
SUMMARY:
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lotter on DSK11XQN23PROD with NOTICES1
37990
Federal Register / Vol. 86, No. 135 / Monday, July 19, 2021 / Notices
Supporting documents and any
comments we receive on this docket
may be viewed at www.regulations.gov
or in our reading room, which is located
in room 1620 of the USDA South
Building, 14th Street and Independence
Avenue SW, Washington, DC. Normal
reading room hours are 8 a.m. to 4:30
p.m., Monday through Friday, except
holidays. To be sure someone is there to
help you, please call (202) 799–7039
before coming.
FOR FURTHER INFORMATION CONTACT: For
information on the National Poultry
Improvement Plan, contact Dr. Elena
Behnke, DVM, Senior Coordinator,
National Poultry Improvement Plan,
Veterinary Services, APHIS, 1506
Klondike Road SW, Suite 101, Conyers,
GA 30094; (770) 922–3496. For more
detailed information on the information
collection, contact Mr. Joseph Moxey,
APHIS’ Paperwork Reduction Act
Coordinator, at (301) 851–2483.
SUPPLEMENTARY INFORMATION:
Title: National Poultry Improvement
Plan.
OMB Control Number: 0579–0007.
Type of Request: Revision to and
extension of approval of an information
collection.
Abstract: Under the Animal Health
Protection Act (7 U.S.C. 8301 et seq.),
the Animal and Plant Health Inspection
Service (APHIS) of the U.S. Department
of Agriculture is authorized, among
other things, to administer the National
Poultry Improvement Plan (NPIP), the
primary purpose of which is to protect
the health of the U.S. poultry
population. NPIP is a Federal-Stateindustry cooperative program for the
improvement of poultry flocks and
products through disease control
techniques. Participation in all NPIP
programs is voluntary, but flocks,
hatcheries, and dealers of breeding
poultry must first qualify as ‘‘U.S.
Pullorum-Typhoid Clean’’ as a
condition for participation in NPIP
programs. The NPIP regulations are
contained in 9 CFR part 56 and parts
145 through 147.
To administer the NPIP, APHIS
requires a number of activities that
include memoranda of understanding;
flock selecting and testing reports and
commercial waterfowl/game bird egg
producing flock surveillance; reports of
sales of hatching eggs, chicks and poults
(including printing and mailing
computerized printouts for small
shipments); summaries of breeding
flock, table-egg layer flock, meat-type
chicken and turkey slaughter plant
participation; reports of hatcheries,
dealers, and independent flocks, tableegg producers, meat-type chicken and
VerDate Sep<11>2014
18:23 Jul 16, 2021
Jkt 253001
turkey slaughter plants participating in
the NPIP; investigations of salmonella
isolations in poultry; flock inspection
and check testing reports; and hatchery
inspection forms. Activities also include
banding or marking of sentinel birds for
identification prior to flock vaccination;
requests for salmonella serotyping;
applications for U.S. Avian influenza
and Newcastle Clean Compartment and
Clean Component Registrations and
requests for removal; component audits;
auditor applications for NPIP AI Clean
Compartment Program; and compliance
statements. Activities further include
descriptions of animal identification
and traceability processes; laboratory
examination for Newcastle disease and
reporting; diagnostic test evaluations;
Newcastle disease biosecurity plans;
indemnity compliance agreements;
appraisal and indemnity claims for
animals or materials destroyed; initial
state response and containment plan;
and recordkeeping.
The information collection
requirements listed above represent
activities currently filed under Office of
Management and Budget (OMB) control
number 0579–0007, National Poultry
Improvement Plan, and OMB control
number 0579–0474, National Poultry
Improvement Plan and Auxiliary
Provisions. After OMB approves this
combined information collection
package (0579–0007), APHIS will retire
OMB control number 0579–0474.
We are asking OMB to approve our
use of these information collection
activities, as described, for an additional
3 years.
The purpose of this notice is to solicit
comments from the public (as well as
affected agencies) concerning our
information collection. These comments
will help us:
(1) Evaluate whether the collection of
information is necessary for the proper
performance of the functions of the
Agency, including whether the
information will have practical utility;
(2) Evaluate the accuracy of our
estimate of the burden of the collection
of information, including the validity of
the methodology and assumptions used;
(3) Enhance the quality, utility, and
clarity of the information to be
collected; and
(4) Minimize the burden of the
collection of information on those who
are to respond, through use, as
appropriate, of automated, electronic,
mechanical, and other collection
technologies; e.g., permitting electronic
submission of responses.
Estimate of burden: The public
burden for this collection of information
is estimated to average 0.475 hours per
response.
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Respondents: State agriculture
officials; flock owners; breeders;
hatchery operators; table-egg, meat-type
chicken, and meat-type turkey
producers; feedlot and slaughter plant
personnel; approved laboratory
personnel; prospective and certified
auditors; visitors; and associated
entities.
Estimated annual number of
respondents: 2,867.
Estimated annual number of
responses per respondent: 82.
Estimated annual number of
responses: 234,630.
Estimated total annual burden on
respondents: 111,339 hours. (Due to
averaging, the total annual burden hours
may not equal the product of the annual
number of responses multiplied by the
reporting burden per response.)
All responses to this notice will be
summarized and included in the request
for OMB approval. All comments will
also become a matter of public record.
Done in Washington, DC, this 6th day of
July 2021.
Jack Shere,
Acting Administrator, Animal and Plant
Health Inspection Service.
[FR Doc. 2021–15185 Filed 7–16–21; 8:45 am]
BILLING CODE 3410–34–P
DEPARTMENT OF AGRICULTURE
Farm Service Agency
[Docket ID FSA–2021–0007]
Notice of Funds Availability; Pandemic
Livestock Indemnity Program (PLIP)
Farm Service Agency,
Agriculture (USDA).
ACTION: Notification of funding
availability.
AGENCY:
The Farm Service Agency
(FSA) is issuing this notice announcing
the availability of funds for the
Pandemic Livestock Indemnity Program
(PLIP) to provide assistance to
producers for losses of livestock and
poultry depopulated from March 1,
2020, through December 26, 2020, due
to insufficient processing access as a
result of the COVID–19 pandemic and
for the cost of depopulation and
disposal. FSA is implementing PLIP, as
authorized by the Consolidated
Appropriations Act, 2021 (CAA).
FOR FURTHER INFORMATION CONTACT:
Kimberly Graham, Director; telephone:
(202) 720–6825; email:
Kimberly.Graham@usda.gov. Persons
with disabilities who require alternative
means for communication should
contact the USDA Target Center at (202)
SUMMARY:
E:\FR\FM\19JYN1.SGM
19JYN1
]]>Agencies
[Federal Register Volume 86, Number 135 (Monday, July 19, 2021)]
[Notices]
[Pages 37989-37990]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2021-15185]
-----------------------------------------------------------------------
DEPARTMENT OF AGRICULTURE
Animal and Plant Health Inspection Service
[Docket No. APHIS-2021-0032]
Notice of Request for Revision to and Extension of Approval of an
Information Collection; National Poultry Improvement Plan
AGENCY: Animal and Plant Health Inspection Service, Agriculture (USDA).
ACTION: Revision to and extension of approval of an information
collection; comment request.
-----------------------------------------------------------------------
SUMMARY: In accordance with the Paperwork Reduction Act of 1995, this
notice announces the Animal and Plant Health Inspection Service's
intention to request a revision to and extension of approval of an
information collection associated with the National Poultry Improvement
Plan.
DATES: We will consider all comments that we receive on or before
September 17, 2021.
ADDRESSES: You may submit comments by either of the following methods:
Federal eRulemaking Portal: Go to www.regulations.gov.
Enter APHIS-2021-0032 in the Search field. Select the Documents tab,
then select the Comment button in the list of documents.
Postal Mail/Commercial Delivery: Send your comment to
Docket No. APHIS-2021-0032, Regulatory Analysis and Development, PPD,
APHIS, Station 3A-03.8, 4700 River Road, Unit 118, Riverdale, MD 20737-
1238.
[[Page 37990]]
Supporting documents and any comments we receive on this docket may
be viewed at www.regulations.gov or in our reading room, which is
located in room 1620 of the USDA South Building, 14th Street and
Independence Avenue SW, Washington, DC. Normal reading room hours are 8
a.m. to 4:30 p.m., Monday through Friday, except holidays. To be sure
someone is there to help you, please call (202) 799-7039 before coming.
FOR FURTHER INFORMATION CONTACT: For information on the National
Poultry Improvement Plan, contact Dr. Elena Behnke, DVM, Senior
Coordinator, National Poultry Improvement Plan, Veterinary Services,
APHIS, 1506 Klondike Road SW, Suite 101, Conyers, GA 30094; (770) 922-
3496. For more detailed information on the information collection,
contact Mr. Joseph Moxey, APHIS' Paperwork Reduction Act Coordinator,
at (301) 851-2483.
SUPPLEMENTARY INFORMATION:
Title: National Poultry Improvement Plan.
OMB Control Number: 0579-0007.
Type of Request: Revision to and extension of approval of an
information collection.
Abstract: Under the Animal Health Protection Act (7 U.S.C. 8301 et
seq.), the Animal and Plant Health Inspection Service (APHIS) of the
U.S. Department of Agriculture is authorized, among other things, to
administer the National Poultry Improvement Plan (NPIP), the primary
purpose of which is to protect the health of the U.S. poultry
population. NPIP is a Federal-State-industry cooperative program for
the improvement of poultry flocks and products through disease control
techniques. Participation in all NPIP programs is voluntary, but
flocks, hatcheries, and dealers of breeding poultry must first qualify
as ``U.S. Pullorum-Typhoid Clean'' as a condition for participation in
NPIP programs. The NPIP regulations are contained in 9 CFR part 56 and
parts 145 through 147.
To administer the NPIP, APHIS requires a number of activities that
include memoranda of understanding; flock selecting and testing reports
and commercial waterfowl/game bird egg producing flock surveillance;
reports of sales of hatching eggs, chicks and poults (including
printing and mailing computerized printouts for small shipments);
summaries of breeding flock, table-egg layer flock, meat-type chicken
and turkey slaughter plant participation; reports of hatcheries,
dealers, and independent flocks, table-egg producers, meat-type chicken
and turkey slaughter plants participating in the NPIP; investigations
of salmonella isolations in poultry; flock inspection and check testing
reports; and hatchery inspection forms. Activities also include banding
or marking of sentinel birds for identification prior to flock
vaccination; requests for salmonella serotyping; applications for U.S.
Avian influenza and Newcastle Clean Compartment and Clean Component
Registrations and requests for removal; component audits; auditor
applications for NPIP AI Clean Compartment Program; and compliance
statements. Activities further include descriptions of animal
identification and traceability processes; laboratory examination for
Newcastle disease and reporting; diagnostic test evaluations; Newcastle
disease biosecurity plans; indemnity compliance agreements; appraisal
and indemnity claims for animals or materials destroyed; initial state
response and containment plan; and recordkeeping.
The information collection requirements listed above represent
activities currently filed under Office of Management and Budget (OMB)
control number 0579-0007, National Poultry Improvement Plan, and OMB
control number 0579-0474, National Poultry Improvement Plan and
Auxiliary Provisions. After OMB approves this combined information
collection package (0579-0007), APHIS will retire OMB control number
0579-0474.
We are asking OMB to approve our use of these information
collection activities, as described, for an additional 3 years.
The purpose of this notice is to solicit comments from the public
(as well as affected agencies) concerning our information collection.
These comments will help us:
(1) Evaluate whether the collection of information is necessary for
the proper performance of the functions of the Agency, including
whether the information will have practical utility;
(2) Evaluate the accuracy of our estimate of the burden of the
collection of information, including the validity of the methodology
and assumptions used;
(3) Enhance the quality, utility, and clarity of the information to
be collected; and
(4) Minimize the burden of the collection of information on those
who are to respond, through use, as appropriate, of automated,
electronic, mechanical, and other collection technologies; e.g.,
permitting electronic submission of responses.
Estimate of burden: The public burden for this collection of
information is estimated to average 0.475 hours per response.
Respondents: State agriculture officials; flock owners; breeders;
hatchery operators; table-egg, meat-type chicken, and meat-type turkey
producers; feedlot and slaughter plant personnel; approved laboratory
personnel; prospective and certified auditors; visitors; and associated
entities.
Estimated annual number of respondents: 2,867.
Estimated annual number of responses per respondent: 82.
Estimated annual number of responses: 234,630.
Estimated total annual burden on respondents: 111,339 hours. (Due
to averaging, the total annual burden hours may not equal the product
of the annual number of responses multiplied by the reporting burden
per response.)
All responses to this notice will be summarized and included in the
request for OMB approval. All comments will also become a matter of
public record.
Done in Washington, DC, this 6th day of July 2021.
Jack Shere,
Acting Administrator, Animal and Plant Health Inspection Service.
[FR Doc. 2021-15185 Filed 7-16-21; 8:45 am]
BILLING CODE 3410-34-P
